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Norethindrone - Generic Drug Details

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Norethindrone is the generic ingredient in twelve branded drugs marketed by Aurobindo Pharma Ltd, Accord Hlthcare, Glenmark Generics, Novast Labs Ltd, Lupin Ltd, Mayne Pharma, Janssen Pharms, Apil, Amneal Pharms, Novast Labs, Mylan Labs Ltd, Parke Davis, Duramed Res, and Barr, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for norethindrone. Eighteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: norethindrone

Tradenames:12
Patents:0
Applicants:14
NDAs:23
Drug Master File Entries: see list26
Suppliers / Packagers: see list18
Bulk Api Vendors: see list40
Clinical Trials: see list18
Patent Applications: see list6,485
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:norethindrone at DailyMed

Pharmacology for Ingredient: norethindrone

Ingredient-typeProgesterone Congeners
Drug ClassProgestin

Tentative approvals for NORETHINDRONE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL1MG;0.01MG;75MG
<disabled><disabled>TABLET;ORAL1MG;0.02MG
<disabled><disabled>TABLET;ORAL75MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novast Labs Ltd
NORETHINDRONE
norethindrone
TABLET;ORAL-28202014-001Sep 13, 2013RXNoNo► subscribe► subscribe
Aurobindo Pharma Ltd
INCASSIA
norethindrone
TABLET;ORAL-28207304-001Sep 23, 2016RXNoNo► subscribe► subscribe
Mylan Labs Ltd
NORETHINDRONE
norethindrone
TABLET;ORAL-28201483-001Jun 24, 2013RXNoNo► subscribe► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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